Impella RP Flex with SmartAssist has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA), the FDA’s highest level of approval, as safe and effective to treat acute right heart failure for up to 14 days.
Key clinical benefits of Impella RP Flex include:
- Single venous access via the internal jugular (IJ) vein and 11 French (Fr) indwelling catheter, facilitating patient mobility
- Flexible cannula advanced over an extra-support guidewire, enabling ease of insertion and pump delivery
- SmartAssist dual-sensor technology with Impella Connect, providing advanced metrics to help with pump management and weaning
- Heparin-free purge, simplifying patient anticoagulant management with the use of sodium bicarbonate where heparin is of concern due to heparin intolerance or bleeding